Job Listing
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| Job ID: 14038336 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Sr. Clinical Research Associate |
| Work Type: | Work Days: Work Vary: Yes , Shift: Other, Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
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| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | Bachelor's Degree |
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| Experience Required: | Unspecified |
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| Required Skills: | Please see the job description for information about required job skills. |
| Preferred Skills: |
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| Job Description: |
Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina - long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life.
Position Overview
The Sr. Clinical Research Associate (Sr. CRA) will be responsible for establishing, managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. They will be accountable for clinical project management activities, for coordination with cross-functional counterparts and contract research organizations (CROs) in global studies. This position requires strategic, project and resource management responsibilities for the assigned clinical program(s) to evaluate the safety and effectiveness of interventional products. This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned.
Essential Job Functions
Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.
Manage study preparation, activation, enrollment, submission, maintenance and closure activities.
Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
Interface with representatives from key functional groups to drive product development within core teams, and clinical wide or cross-departmental initiatives.
Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories.
Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
Supervise training of investigators, site staff and field clinical staff.
Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
Regularly communicates study status to senior management and represents organization to key customers.
Other duties as assigned.
Requirements
Bachelor's Degree in a scientific field of study with a minimum of 5 years' experience directly supporting clinical research
Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations)
Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting
ACRP or SOCRA clinical research certification preferred
Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Ability to travel up to 25% domestically and internationally
High attention to detail and accuracy
Computer skills (MS Office products, word processing, spreadsheets, etc.)
Finance and budgeting knowledge
Good prioritization and organizational skills
Excellent critical thinking skills
Excellent influencing and negotiation skills
High energy and results-oriented individual who is mature and successful in a business environment
Proactive and "can do" attitude
Works effectively on cross-functional teams
Effective written, verbal and presentation skills with all levels of management and organizations
Operates both as a team and independently, with adaptability to changing requirements
Ability to work in a fast-paced environment, managing multiple priorities
Market Range: $92,000 - $114,000
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits:Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer
Shockwave Medical Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
Refer to ID 79107677 when applying |
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